Tampon Saturation Monitoring System

ABSTRACT

A tampon that has a sensor and a signal line that peripherally connects the sensor with a peripheral signal processor. The sensor provides an optic blood wetting signal in response to a progressing blood saturation boundary in the tampon. The simple sensor has two proximal signal terminals separated by a fluid responsive medium in wetting communication with the tampon&#39;s body. The tampon may be removed by use of the signal line. From signal timing and/or signal gradient the processor may predict when the tampon needs to be changed.

PRIORITY CLAIM

The present application is a Continuation of application Ser. No.11/673,373, filed Feb. 0, 2007 of the same title and inventor, to andfrom which priority is claimed herewith.

FIELD OF INVENTION

The present invention relates to systems and devices for monitoring themenstrual blood saturation progress in vaginally inserted tampons.

BACKGROUND OF INVENTION

Tampons are conveniently used by women to absorb menstrual blood. Forthat purpose a tampon is commonly vaginally inserted. The tampon acts asa fluid absorption body that seals at the same time the vaginal channeland absorbs menstrual blood from the uterus until the tampon reaches itsfluid absorption limit. If the tampon is not replaced at that time,menstrual blood may leak out of the tampon.

For a woman it may be difficult to predict when the tampon has reachedits fluid absorption limit. Therefore, there exists a need for a systemfor monitoring the saturation progress of a vaginally inserted tampon.The present invention addresses this need.

During the menstrual period a large number of tampons may be needed andreplaced in short time intervals. Therefore, there exists a need for atampon saturation monitoring system that utilizes simple and inexpensiveyet reliable sensor configurations. The present invention addresses alsothis need.

There exists also a need for a tampon user to receive a preemptiveforecast when a tampon in use may reach its fluid saturation limit. Thepresent invention addresses also this need.

SUMMARY OF INVENTION

A tampon saturation monitoring system of the present invention featuresa tampon that has a saturation sensor positioned inside the fluidabsorption body and a first signal line that peripherally connects thesaturation sensor with a peripheral signal processor. The fluidsaturation sensor provides a wetting response signal in conjunction witha blood saturation boundary that is axially progressing along the fluidabsorption body.

The saturation sensor is a simple device including at least two proximalsignal terminals separated by a fluid responsive medium that ispreferably made of the same gauze material as the fluid absorption bodyis fabricated from. The two proximal signal terminals have a signalpotential across the fluid responsive medium, which is in wettingcommunication with the fluid absorption body. The saturation sensor maybe configured to provide a resistive, capacitive or optic wettingresponse signal, which the processor computes to derive information ofthe saturation boundary progress of the fluid absorption body. Theprocessed saturation information is passed on to a saturation notifier,which may be a buzzer, a tactile notifier in skin contact or a softwareapplication installed on a portable multifunction device.

The processor may also compute from signal timing and/or signal gradienta forecast of the moment, when the tampon will reach its fullsaturation. In that way, a tampon user may conveniently plan ahead totimely replace the inserted tampon.

The first signal line may be a cable that is structurally combined withthe fluid absorption body such that the tampon may be pulled from itsvaginally arrested position by use of the cable. The cable may feature aconnector to easily connect and/or disconnect to the processor. Theprocessor may be configured as a disposable device with a battery lifecorresponding to a predetermined number of tampons with which theprocessor may be packaged together in a set. The processor may also beconfigured as a standalone unit with a replaceable battery.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a schematic view of a first embodiment of the invention invaginally inserted position.

FIG. 2 is a schematic view of a tampon with a saturation sensoraccording to a second embodiment of the invention.

FIG. 3 is a schematic view of a third embodiment of the invention.

FIG. 4 is a schematic view of a fourth embodiment of the invention.

FIG. 5 is a schematic partial view of a tampon of the present invention.

FIG. 6 is a schematic cross section view of a tampon including asaturation sensor capacitor.

FIG. 7 is a schematic view of a fifth embodiment of the presentinvention at an intermediated fabrication stage.

FIG. 8 is a representative diagram of blood saturation progress in atampon and correlated saturation signals and signal timing.

DETAILED DESCRIPTION

Referring to FIGS. 1-4, a tampon saturation monitoring system 10includes a tampon 11, a signal processor 14 and a notifier 15. Thetampon 11 has a well known fluid absorption body 111 as commonly used incommercially available tampons, a saturation sensor 120 and a firstsignal line 114, which is preferably a cable. The fluid absorption body111 protrudes along a saturation progress axis 11X. The fluid absorptionbody 111 has a fluid access end 112 and a peripheral end 113 opposite tothe fluid access end 112 in direction of the saturation progress axis11X. While the tampon 11 is positioned in the vaginal channel 1,menstrual blood from the uterus is mainly absorbed by the fluidabsorption body 111 in the vicinity of the fluid access end 112 andaxially progressing substantially in direction along the saturationprogress axis 11X. The more blood is absorbed, the further progressesthe blood saturation boundary 2 towards the peripheral end 113.

Should the blood saturation boundary 2 reach the peripheral end 113,blood may seep out of the tampon 11 as may be well appreciated by anyoneskilled in the art. To prevent this from happening and to give thetampon 11 user sufficiently early warning, the saturation sensor 120 ispositioned axially with respect to the saturation progress axis 11Xgenerally in between the fluid access end 112 and the peripheral end113, preferably in close proximity to the peripheral end 113. Thesaturation sensor 120 includes preferably two proximal signal terminals121A, 121B having a signal potential across a fluid responsive medium122 that is separating the signal terminals 121A, 121B.

The fluid responsive medium 122 is in a wetting communication with thefluid absorption body 111. This means that as the saturation boundary 2axially progresses past the saturation sensor 120, the menstrual bloodfollowing the saturation boundary 2 is wetting the fluid responsivemedium 122.

As the saturation boundary 2 penetrates the fluid responsive medium 122,a wetting response signal S is generated in conjunction with the axiallyprogressing saturation boundary 2. This means, that the portion of thesaturation sensor 120 through which the saturation boundary 2 alreadypassed and along which the fluid response medium 122 is wetted, thesignal potential between the two proximal signal terminals 121A, 121B isactivated by a change of physical properties in the fluid responsivemedium 122 due to the wetting. The physical properties change mayinclude a change of electric resistance, dimensional spacing, lightattenuation, and/or light filtering as explained in more detail in thebelow.

In a particular case in which the saturation sensor 120 extendssubstantially axially along the saturation progress axis 11X as depictedin the FIGS. 1-5, the wetting communication may be radially and axiallyresponsive to the saturation boundary 2 while progressing in between thefrontal end 124 and the rear end 125 of the saturation sensor 120. Inthat case, the wetting response signal S may be gradual and in aproportion to the axially progressing saturation boundary 2 in theradial vicinity of the saturation sensor 120 in between its frontal endrear ends 124, 125. From the gradual wetting response signal S, theprocessor 14, and/or the notifier 15 may provide a tampon 11 fullforecast, which may include a time span until the tampon 11 reaches itsfluid absorption limit and optionally an forecast error margin. Aforecast error margin may consider fluctuations in the axial progressionof the saturation boundary 2 as may well occur due to varying menstrualbleeding.

In embodiments in which the wetting response signal S is a resistivesignal occurring between two proximal signal terminals 121A, 121Bconfigured as electrical conductors, any stray current flow from theproximal signal terminals 121A, 121B to the vaginal lining 1 may need tobe kept below a well established body leakage current maximum as is wellknown to anyone skilled in the art. According to the well known Ohm'slaw, a current flow for a given conductivity is proportional to thevoltage difference along the conductive path. Hence, the voltagedifference between the proximal signal terminals 121A, 121B may beselected sufficiently low and independently of a processing voltage ofthe processor 14. The processing voltage may be a voltage required bythe logic circuitry inside the processor 14. The voltage differencebetween the signal terminals 121A, 121B may be a fraction of theprocessing voltage and selected in conjunction with a predeterminedconductivity between at least one of the signal terminals 121A, 121B andthe proximal vaginal lining 1 and the maximum allowed body leakagecurrent. At the time the invention was made, the maximum allowed bodyleakage current known to the inventor is 10 microampere. The processor14 may feature a processing circuitry 146 that operates at theprocessing voltage and a low voltage circuitry 145 that provides thevoltage difference at a fraction of the processing voltage.

The present invention includes embodiments with more than two signalterminals 121A, 121B which may be radially spread across a cross sectionof the tampon 11 to capture eventual axial progress fluctuations of thesaturation boundary 2. In such a case, the wetting response signal S maybe summed and averaged by the processor 14 and/or balanced within thesaturation sensor 120 by grouping and conductively connecting the numberof proximal signal terminals 121A, 121B in two sets.

The first signal line 114 peripherally connects the saturation sensor120 across the peripheral end 113 with the signal processor 14preferably via a connector 115. The signal processor 14 computes fromthe wetting response signal S a progress of the saturation boundary 2.The notifier 15, which is in communication with the signal processor 14notifies the tampon 11 user about the saturation boundary 2 progress.

In a first embodiment of the invention, the at least two proximal signalterminals 121A, 121B are electric conductors. The physical propertychange of the fluid responsive medium 122 due to menstrual blood wettingmay be an electric resistance change. The wetting response signal S mayoccur in between the electric conductors 121A, 121B and across the fluidresponsive medium 122 in conjunction with electric resistance change anda voltage difference between the two electric conductors 121A, 121B. Thevoltage difference may be applied by the processor 14 via the connector115 and the cable 114.

The electric resistance change may result from the menstrual blood thatis wetting the fluid responsive medium 122. Blood has a well knownconductivity due to its iron content as is well known in the art. Thefluid responsive medium 122 may be configured with a dry conductivitythat substantially differs from the blood's conductivity to provide theelectric resistance change in conjunction with its blood wetting. Asdepicted in FIG. 2, one of the electric conductors 121A may be anenveloping conductor 121A encapsulating the second electric conductor121B and acting as an electric ground. As a result, eventual electriccurrent flow due the electric resistance change may be contained withinthe enveloping conductor 121A irrespective an eventual outsideconductive path of the absorbed blood outside the saturation sensor 120.The outside conductive path may be related to the wetting communicationof the fluid responsive medium 122 with the fluid absorption body 111.

The wetting communication across the enveloping conductor 121A may bewarranted by configuring the enveloping conductor as fluid permeablesuch a metal mesh, metal weaving and/or perforated metal foil. In caseof a coaxial cable employed as the first signal line 114, the envelopingconductor 121A may be an integral conductive part of the coaxial cable's114 shielding mesh. A shielding mesh may be the well known part of acoaxial cable 114 circumferentially protruding along the cable 114 toelectrically and/or magnetically shield core wires against thesurrounding environment as is well known in the art.

The first signal line 114 is preferably a cable 114 such as an opticfiber cable or an electric cable such as an unshielded strand cable or acoaxial cable as described above. The cable 114 may be structurallycombined with the fluid absorption body 111 such that the tampon 11 maybe pulled out of its vaginally arrested position 1 via said cable 114.In the preferred case in which the fluid absorption body 111 is made ofrolled up gauze as is well known in the art, the cable 114 may beknotted with the gauze at the peripheral end 113. In that way, tensilestress during the pull out of the tampon 11 is conveniently transferredfrom the cable 114 onto the fluid absorption body 111 via the knot 118.At the same time, the knot 118 may serve to transfer eventual cable 114stress during tampon 11 use onto the fluid absorption body 111 such thatthe saturation sensor 120 remains free of cable 114 stress at a constantposition within the fluid absorption body 111. The constant position mayassist in providing a more accurate tampon full forecast.

At least one of the proximal signal terminals 121A, 121B may be integralpart of a strand of the cable 114. In case of an optic cable 114, thestrand may be an optic fiber. In case of an electric cable 114, thestrand may be an electric wire strand or as described above a shieldingmesh. As depicted in FIG. 5, the strands of the proximal signalterminals 121A, 121B may be separated and spaced from each other by anumber of spacers 117 that are axially arrayed with respect to thesaturation progress axis 11X. The cable 114 may feature a well knownsurrounding insulation 1141 and the spacer(s) 117 may be of thatsurrounding insulation 117. In that way, the saturation sensor 120 maybe simply fabricated from the cable 114 by separating a number ofspacers 117 from the surrounding insulation 1141 in a way such thattheir encapsulating structural integrity remains intact. The cable 114strands may be exposed to the fluid responsive medium 122, by slidingthe separated spacers 117 along the strands. In that way constantspacing between the proximal signal terminals 121A, 121B is warranted ina simple fashion during fabrication.

The fluid responsive medium 122 may be integral part of the fluidabsorption body 111. In the preferred case of the fluid absorption body111 being made of a well known gauze material, the saturation sensor 120may be fabricated by interweaving separated proximal signal terminals121A, 121B with the gauze material and/or roll them up together withgauze material such that the proximal signal terminals 121A, 121B arepreferably at a central location of the fully fabricated tampon 11. Theknot 118 may be fabricated prior to rolling up the gauze material.

Referring to FIG. 6, the proximal signal terminals 121A, 121B and thefluid responsive medium 122 may define together a capacitor. The wettingresponse signal S may be an electric capacitance change of thesaturation sensor 120. The electric capacitance change may result from awetted swelling of the fluid responsive medium. The wetted swelling mayoccur as the fluid responsive medium absorbs menstrual blood. The wettedswelling may push the proximal signal terminals 121A, 121B furtherapart, which reduces the capacitance between the proximal signalterminals 121A, 121B according to the well known principles of anelectric capacitor. The proximal signal terminals 121A, 121B may beinterweaved rolled up perforated metal foils separated by the fluidresponsive medium 122. The metal foils 121A, 121B perforation mayprovide for the wetting communication across metal foils 121A, 121B. Thefluid responsive medium 122 may again be from the same gauze material asthe fluid absorption body 111. The perforated metal foils 121A, 121B maybe rolled up together with the fluid absorption body 111, making thetampon 11 fabrication very simple and inexpensive. In addition, themetal foils 121A may feature an insulating coating such that no electriccurrent flow may occur inside the fluid absorption body 111 irrespectivethe presence of eventually conductive blood.

Referring to FIG. 3, the saturation sensor 120 may be an optical bridgefeaturing a light emitter 121A proximal to a light receiver 121B. Theseparating fluid responsive medium 122 may be optically responsive. Thewetting response signal S may be a light attenuation change and/or alight spectrum change of the fluid responsive medium 122 in response tothe blood wetting of the fluid responsive medium 122. At least one butpreferably both light emitter 121A and light receiver 121B may beintegral optic fiber strands of the cable 114 extending into thesaturation sensor 120. The fluid responsive medium 122 may be of a gauzematerial of a thickness and optic permeability suitable for attainingthe desired optic responsiveness as may be well appreciated by anyoneskilled in the art.

The processor 14 may feature a light source 141 and a light sensor 142optically connected to the cable 114 via connector 115. The light source141 pumps light across the connector 115 and through the cable 114 intothe fiber end 121A, which may be stripped off its reflective coatingand/or otherwise processed in a well known fashion such that the lightmay emerge laterally from the exposed fiber end 121A. The light receiverfiber 121B may also be processed in a well known fashion such that someof the light emitted from the emitting fiber 121A and passing throughthe fluid responsive medium 122 is caught in the receiving fiber end121B and transmitted via the fiber optic cable 114 and across theconnector 115 back to the light sensor 142.

According to FIG. 4, light emitter 121A and light receiver 121B may becombined in conjunction with a well known optic gate 143 in theprocessor 14. The optic gate 143 redirects the returning light beamtowards the light sensor 142 while switching through the light from thelight source 141 towards the saturation sensor 120. In such a singlesignal terminal 121 configuration, the fluid responsive medium 122 maybe reflectively optically responsive such that light emitted from thesingle signal terminal 121 is back reflected while attenuated and/orspectral changed. The reflection may be diffuse in case of aconventional gauze material utilized as the fluid responsive medium 122.As a favorable result, the single fiber saturation sensor 120 is highlyconsistent in its wetting response signal S strength since there are nospacing fluctuations between emitter and receiver that eventually reducesignal precision and repeatability.

The notifier 15 may be an acoustic notifier such as a buzzer. Accousticnotification may vary in tone, loudness, and/or time interval to providea distinguishable information to the user about the tampon's 11saturation boundary 2 progress. The notifier 15 may also be a tactilenotifier such as a vibrating element configured for skin transmittedvibration notification. The notifier 15 may be structurally separatedfrom the processor 14 and in wireless communication with the processor14 via a second signal line 119. In that way, the processor may becarried conveniently attached to undergarment in proximity to tampon 11whereas the notifier 15 may be positioned at a location suitable forcommunication to and/or with the tampon 11 wearer.

The notifier 15 may be a software application installed on a portablemultifunction device such as but not limited to a cellular phone or ahandheld computing device. At the time of this invention, portablemultifunction devices include features such as wireless communicationcapabilities well known under the term Bluetooth™ that are suitable forcommunicating with peripheral devices such as the processor 14. Uponinstallation of the notifier 15 software, the portable multifunctiondevice may provide, visual, acoustic or other well known notificationvia its built in hardware features.

Referring to FIG. 7, an embodiment of the invention features the fluidresponsive medium 122 as integral part of the fluid absorption body 111,which may be of a gauze material coiled into a cylindrical shape. InFIG. 7, an intermediate fabrication stage of the tampon 11 isschematically depicted at which the gauze material 111/122 may be stillin uncoiled condition. The first signal line 114 in the preferredconfiguration of a cable may be sewed on the gauze material 111/122 viaseams 16 such that operational tampon 11 may be pulled out of thevaginally arrested position 1 via the cable 114. Sewing may beparticularly suitable since it provides for an axially straightintegration of the cable 114 inside the fluid absorption body 111, whichassists the coiling of the gauze material 111/122 around saturationprogress axis 11X as may be well appreciated by anyone skilled in theart. Optionally, the backwards bending signal terminal(s) 121A, 121B mayalso be sewed on to the gauze material 111/122.

Separation and spacing between signal terminals 121A, 121B may beprovided by the gauze material 111/122. This may be accomplished byhaving one signal terminal 121 backwards bending through an optionalhole 1113 in the gauze material 111/122. The signal terminal 121A isdepicted in FIG. 7 in dashed lines to indicate it being on the backsideof the gauze material 111/122.

At least one but preferably all proximal signal terminals 121A, 121B arepreferably integral part of the cable 114 and backwards bendingextending from the sewed on portion of the cable 114 such that thesignal terminal ends 1213A, 1213B are in immediate proximity to theperipheral end 113. As a favorable result, the progress of the bloodsaturation boundary 2 may be monitored closest to the peripheral end 113such that a user of the tampon saturation monitoring system 10 may benotified with highest precision till the very moment the tampon 11reaches its fluid absorption limit. The cable signal terminals 121A,121B may be composed of thin wire strands held together by the spacers117.

The signal processor 14 may be a simple micro controller. Its circuitrymay be configured and/or programmed to reset during disconnection orconnection of a connector 115 indicating a tampon 11 change. Referringto FIG. 8 and upon connection of the connector 115 with the processor 14at T0, the saturation sensor 120 may be tested as is well known in theart. A calibration signal S0 may be received from the processor 14during initial testing. The moment T0 of initial connection may berecorded by the processor 14 as well as a second moment T1 of initialreceive of the wetting response signal S1. Second moment T1 happens whenthe saturation boundary 2 has progressed so far as to reach the frontalend of the saturation sensor 120. In the case of a saturation sensor 120configuration that provides a gradual and proportional wetting responsesignal S as described above, the wetting response signal S may increasein amplitude as the saturation boundary 2 progresses axially along thesaturation sensor 120. This is reflected in the graph of FIG. 8 by theinclining portion of the curve 2C within the boundaries of thesaturation sensor 120.

The processor 14 may time an initial signal delay DTO between the firstmoment T0 and second moment T1. In case of an estimated progressionbehavior of the saturation boundary 2 as depicted by the curve 2C inFIG. 8, the processor 14 may process the tampon 11 full forecast DTF1from the initial signal delay DTO and an from initial amplitude of thewetting response signal S1. Any wetting response signals at and belowthe testing amplitude S0 may be disregarded by the processor 14 andsignal processing may initiate with the initial measurement at T1 atwhich the signal amplitude is above the testing signal S0 amplitude.

Additional measurements may be performed by the processor 14 in timeintervals DTX and the tampon 11 full forecast DTF2 may becomputationally updated. Signal amplitude of the wetting response signalS2 may be in a difference DS to the initial wetting response signal S1in case of a saturation sensor 120 with gradually and proportionalwetting response signal as described above.

The more measurements are performed the more accurate the tampon 11 fullforecast DTF1, DTF2 may be computed and the error margin for the tampon11 full moment TN brought to a minimum. A user of the tampon saturationmonitoring system 10 can monitor the saturation progress of the tampon11 with a precision that increases as the tampon 11 reaches its fluidabsorption limit at which the wetting response signal SN may have amaximum amplitude.

The interval measurements T1, T2, TN provide for a minimum batteryconsumption and consequently a miniature configuration of the processor14. The battery life of the processor 14 may correspond to apredetermined time of use of a number of tampons 11 packaged togetherwith the processor 14 in a set.

After vaginally inserting the tampon 11, the connector 115 may beconnected with the processor 14 and the saturation sensor 120 may beinitially tested and the connection moment T0 eventually recorded. Theprocessor 14 may be activated but its signal processing remains dormantuntil an initial measurement T1 with an initial signal amplitude S1 thatexceeds test signal amplitude S0 is recognized by the processor 14. Atthe moment T1 the processors computing capacity may be activated and anotification initially passed on to the user via the notifier 15. Theuser's attention is brought to an upcoming tampon 11 change and the usercan conveniently plan ahead to timely change the tampon 11 withoutworrying of missing the tampon's 11 fluid absorption limit.

Accordingly the scope of the present invention described in the figuresand the specification above is set forth by the following claims andtheir legal equivalent:

1. A sensing tampon comprising: a. a fluid absorption body including afluid access end and a peripheral end opposite to said fluid access end;b. a sensor positioned in between said fluid access end and saidperipheral end, said sensor including at least two proximal signalterminals having a signal potential across a fluid responsive mediumthat is separating said at least two proximal signal terminals, saidfluid responsive medium being in a wetting communication with said fluidabsorption body, said sensor generating an optical wetting responsesignal in conjunction with an axially progressing saturation boundary ofsaid body fluid absorption element.
 2. The sensing tampon of claim 1,further comprising a signal cable extending at the peripheral end ofsaid sensing tampon and peripherally connecting said sensor across saidperipheral end.
 3. The sensing tampon of claim 2, wherein at least oneof said at least two proximal signal terminals is integral part of aoptical fiber of said cable.
 4. The sensing tampon of claim 1, whereinsaid fluid responsive medium is integral part of said fluid absorptionbody.
 5. A tampon saturation monitoring system comprising: a. a tamponincluding: i. a fluid absorption body including a fluid access end and aperipheral end opposite to said fluid access end; ii. a saturationsensor extending in between said fluid access end and said peripheralend, said saturation sensor including at least two proximal signalterminals having a signal potential across a fluid responsive mediumthat is separating said at least two proximal signal terminals, saidfluid responsive medium being in a wetting communication with said fluidabsorption body, said fluid saturation sensor generating an opticalwetting response signal in conjunction with an axially progressingsaturation boundary of said body fluid absorption element; b. a signalprocessor in a first communication with said saturation sensor, saidsignal processor monitoring said tampon based on said optical wettingresponse signal; and c. a notifier in communication with said signalprocessor, said notifier providing notification in response to a signalfrom said signal processor.